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510(k) Data Aggregation
(30 days)
WESTAIM BIOMEDICAL, INC.
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(189 days)
WESTAIM BIOMEDICAL, INC.
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(143 days)
WESTAIM BIOMEDICAL, INC.
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(342 days)
WESTAIM BIOMEDICAL, INC.
The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and fungal penetration. The barrier function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. It may be used over debrided and grafted partial thickness wounds. It has not been evaluated in third degree burns.
Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-density polyethylene (HDPE) mesh. The sustained release of silver actively protects the wound site from bacterial and fungal contamination. The dressing will be sold in a variety of sizes.
The provided text does not describe a study to prove the device meets acceptance criteria in the traditional sense of a clinical trial with specific performance metrics. Instead, it is a 510(k) submission summary for the ACTICOAT® Primary Antimicrobial Dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's performance against predefined acceptance criteria through a specific study.
The primary "acceptance criterion" in a 510(k) submission is the demonstration of substantial equivalence to a legally marketed predicate device. This is achieved by comparing the new device's intended use, technological characteristics (design, materials), and safety/effectiveness data to those of the predicate.
Here's how to address the questions based on the provided document:
1. A table of acceptance criteria and the reported device performance
As mentioned, there are no explicit "acceptance criteria" and "reported device performance" in the context of a prospective study for this specific 510(k) submission. The document's closest equivalent is a comparison for substantial equivalence.
| Acceptance Criterion (for 510(k) Equivalence) | Reported Device Performance / Characteristics |
|---|---|
| Intended Use (Wound Dressing) | Yes (Matches predicate) |
| Design: HDPE Skin Contact Layer | Yes (Matches predicate) |
| Design: Absorbable | No (Differs from one predicate, matches another) |
| Design: Antimicrobial silver coating | Yes (Present, distinguishes it from one predicate) |
| Materials (HDPE & Polyurethane backing) | HDPE (Matches predicate) |
| Biocompatibility | Demonstrated through in vivo and in vitro tests |
| Safety and Effectiveness | Substantially equivalent (based on comparison and biocompatibility) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable (N/A). The document does not describe a "test set" in the context of a clinical performance study. The "in vitro testing" mentioned is for antimicrobial effectiveness and biocompatibility, not for assessing wound healing performance against a specific set of test cases.
- Data Provenance: N/A for a clinical performance test set. The biocompatibility and antimicrobial effectiveness data would likely be from laboratory studies, but the document does not specify their origin or whether they were retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. There is no mention of a test set with an established ground truth by experts in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A for clinical performance. For the antimicrobial claim, the "ground truth" would be established by in vitro microbiological testing (e.g., zone of inhibition, bacterial kill rates) against known pathogenic microorganisms, as stated by "based on in vitro testing. Data on file." This type of ground truth is laboratory-based and uses established microbiological assay methods.
- For biocompatibility, the ground truth is established through standard in vivo and in vitro toxicology tests (e.g., cytotoxicity, irritation, sensitization), as mentioned.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. This is not an AI/machine learning device.
Summary of the document's approach:
The ACTICOAT® Primary Antimicrobial Dressing's 510(k) submission relies on:
- Substantial Equivalence: Comparing its intended use and technological characteristics to legally marketed predicate devices (ACTICOAT® Composite dressing and N'Terface dressing). The key difference highlighted is the antimicrobial silver coating, which is also present in one of the predicate devices.
- In vitro testing: To support the antimicrobial claims ("effective barrier to bacterial and fungal penetration") and biocompatibility.
- Previous testing on individual components: For biocompatibility, leveraging existing data for its constituent materials.
The document does not describe a new clinical study to evaluate the device's performance against specific acceptance criteria for wound healing outcomes in humans. Its clearance is based on its similarity to existing devices and positive laboratory findings.
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(89 days)
WESTAIM BIOMEDICAL, INC.
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(41 days)
WESTAIM BIOMEDICAL, INC.
The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted partial thickness wounds.
Acticoat® Composite Wound Dressing is a 3-ply dressing consisting of an absorbent rayon core with an upper layer of polyurethane film and a lower layer of silvercoated high density polyethylene mesh designed to be a barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat® Composite Wound Dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content. abrasion resistance, adhesion, and tensile strength.
The Westaim Corporation's Acticoat® Composite Wound Dressing is a medical device. Here's an analysis of its acceptance criteria and the study that proves its performance, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Acticoat® Composite Wound Dressing are centered around demonstrating that it is substantially equivalent to legally marketed predicate devices, particularly in its performance characteristics and intended use. The performance data presented in the 510(k) summary are essentially the evidence that these criteria have been met.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Material Properties | Silver dissolution | "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." |
| Absorptivity and moisture content | "similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content." and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." | |
| Drop penetration and vapor transmission | "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." | |
| Tensile strength | "similar to those found in untreated gauze-based dressings in the areas of... tensile strength." and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." | |
| Biocompatibility | Skin irritation | "non-irritating" (implied through substantial equivalence to predicate) and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." |
| Sensitization | "non-sensitizing" (implied through substantial equivalence to predicate) and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." | |
| Cytotoxicity | "non-toxic" (implied through substantial equivalence to predicate) and "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." | |
| Silver ion exposure levels | "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." | |
| Antimicrobial Activity | In vitro studies of antimicrobial activity | "both effective for its intended use and functions in a substantially equivalent manner to the predicate devices." |
| Intended Use Equivalence | Barrier to bacterial penetration | "effective barrier to bacterial penetration." and "The barrier function of the dressing may help reduce infection..." |
| General Equivalence | Similar functions, characteristics, and accessories to predicate devices | "The predicate devices also provide the same or similar functions, characteristics, and accessories as described above for the Acticoat® Composite Wound Dressing." and "The dressings have the same intended use and are recommended for the same indications..." |
| Non-toxic, non-irritating, non-sensitizing | "Additionally, both dressings are non-toxic, non-irritating, and non-sensitizing." (referring to both the subject device and predicate silver-coated dressing) | |
| Gas permeable, soft, pliable, cushioning texture | "Similar to the subject device, the silver coated dressing is gas permeable and has a soft, pliable, cushioning texture." | |
| Effective over similar periods of time | "Both the subject dressing and its predicates are effective over similar periods of time (i.e., between dressing changes)." | |
| Low adhesivity to wound site | "The predicate dressings, like the composite wound dressings, also have been shown to have low adhesivity to the wound site." |
The Study that Proves the Device Meets Acceptance Criteria:
The document describes a series of performance tests conducted on the Acticoat® Composite Wound Dressing. These tests were designed to compare the new device's performance against established benchmarks and predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes used for the various performance tests (e.g., silver dissolution, absorptivity, biocompatibility). It simply lists the types of tests performed.
The data provenance is not explicitly stated beyond the tests being performed by "The Westaim Corporation." There's no information regarding the country of origin of data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a wound dressing, these tests would typically be laboratory-based (in-vitro) or animal studies for biocompatibility, rather than human clinical trials for substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable in the context of this 510(k) submission. The "ground truth" for a wound dressing in this type of submission is typically based on established physical properties, chemical analyses, and standardized biological tests rather than expert consensus on diagnostic images or clinical outcomes. The performance tests themselves generate the data that is then compared to accepted standards or predicate device performance.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the tests are largely objective measurements of material properties and biological responses (e.g., cytotoxicity tests under defined conditions), there wouldn't be a need for an adjudication method like 2+1 or 3+1 that is common in clinical imaging studies for establishing ground truth. The results of the tests would be reported directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
This information is not applicable. The Acticoat® Composite Wound Dressing is a physical wound dressing, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. As mentioned above, this is not an AI-powered device.
7. The Type of Ground Truth Used:
The "ground truth" for the acceptance criteria and performance evaluation of the Acticoat® Composite Wound Dressing is based on established scientific and engineering standards and the performance of legally marketed predicate devices.
- Predicate Device Performance: The primary ground truth is the performance characteristics (e.g., absorptivity, tensile strength, antimicrobial effect, biocompatibility) of the Acticoat® Antimicrobial Barrier Dressing (K955453) and Bioderm's Composite Wound Dressing, as well as Conformant 28 Wound Dressing for the wound contact layer. The new device must demonstrate "substantial equivalence" to these.
- Scientific and Engineering Standards: For tests like silver dissolution, absorptivity, tensile strength, and biocompatibility, there are likely industry-standard test methods and acceptance limits that serve as a form of ground truth or benchmark for performance.
- In Vitro/Laboratory Data: The performance tests conducted and reported (e.g., silver dissolution, in vitro antimicrobial activity) provide objective data that is compared to expected or desired outcomes based on these standards and predicate devices.
8. The Sample Size for the Training Set:
This information is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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